drugset / Trial / NCT00135499

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499

Phase 3 Terminated 138 enrolled Lymphoma Study Association Fondation ARC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

Timeline

Start
2001-10-16
Primary completion
2010-04-27
Completion
2010-04-27

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 10 mg
Comparator Cyclophosphamide Other / unclassified 750 mg/m2
Comparator Cyclophosphamide Other / unclassified 1200 mg/m2
Comparator Doxorubicin Other / unclassified 50 mg/m2
Comparator Doxorubicin Other / unclassified 75 mg/m2
Comparator Prednisone Other / unclassified 40 mg
Comparator Prednisone Other / unclassified 60 mg
Comparator Vincristine Small molecule 1.4 mg/m2
Subject Vindesine Small molecule 2 mg/m2
Background Rituximab Monoclonal antibody 375 mg/m2